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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs062190016

Registered date:24/09/2019

A study of using a robot controlling finger movement and botulinum therapy in patients who suffered from stroke

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUpper limb spasticity after stroke
Date of first enrollment01/08/2019
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Botulinum therapy is performed in patients with post-stroke upper limb spasticty including finger joints. Immediately after the therapy robot rehabilitation is done for those treated joints. The same rehabilitation is performed at 1 months after the botulinum therapy, when its effect reaches the maximum. The results are evaluated as measuring the active range of motion of the finger joints, and are compared betwen those immediately after and 1month after the botulinum therapy, so that the additive effect of the botulinum therapy and the robot rehabilitation is explored.

Outcome(s)

Primary Outcome1. Modified Ashworth Scale (MAS) of the finger joints 2. Active ROM (range of motion) of the finger joints
Secondary Outcome1. Fugel-Myer Assessment of the finger joints 2.Brunnstrom stage of the finger joints 3. Visual Analogue Scale by the patient 4. Sensory function (position, kinesithesia) 5. Any technical problems of the robot

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 90age old
GenderBoth
Include criteriaaged 20-90 more than 1 year after the onset of stroke without any recurrence of stroke cognitive function not decreased (HDSR>23) No signs of depression No other active diseases affecting other organs or mental disorders
Exclude criteriaPregnancy Serious systemic diseses Progressive CNS disorders (e.g brain tumors) contractures or severe spasticity of finger joint (MAS=4)

Related Information

Contact

Public contact
Name Ryuji Kaji
Address Narutakiondoyamacho 8, Ukyoku, Kyoto Kyoto Japan 616-8255
Telephone +81-75-461-5121
E-mail kajkyoto@mbox.kyoto-inet.or.jp
Affiliation National Hospital Organization Utano Hospital
Scientific contact
Name Koji Fujita
Address Kuramotocho 3-18-15 Tokushima Japan 770-8503
Telephone +81-88-633-7207
E-mail kfujita@tokushima-u.ac.jp
Affiliation Tokushima University